Evaluation of incidence of sleep disorder and effect of oral almond on sleep quality in medical science students in tehran university of medical sciences
The main goal of the current study is to investigate the impact of sweet almond on quality of sleep. For this purpose, a before-after design will be employed.Study population includes the students residing in Tehran University of Medical Science’s dormitories during the study period. Inclusion criteria: age range of 18 -30 years and informed consent. Exclusion criteria: Being medical intern or resident , having history of psychological disorders. With regard to the previous studies the sample size is 400.Since some of the questionnaires won’t be returned, 450 questionnaires will be distributed to the participants. In the first part of the study, using the Insomnia Severity Index questionnaire, quality of sleep will be determined. It is worth noting that its validity and reliability is previously confirmed by Insomnia Research Institute affiliated to TUMS. Then, each participant will receive 10 almonds each night for a period of 14 days . In the current study each participant will be his/her own control and case. In addition, no placebo will be used in the study. In the second part, the participants will again fill in the questionnaires. The data gathered will be analyzed using SPSS version 23 by Wilcoxon Signed Rank test to investigate the impact of almond on quality of sleep.
General information
Acronym
_
IRCT registration information
IRCT registration number:IRCT2016121131341N1
Registration date:2017-07-07, 1396/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-07, 1396/04/16
Registrant information
Name
Jafar Ghafarzadeh
Name of organization / entity
School of Traditional Medicine, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 5291
Email address
ghafarzadeh.j@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Iran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of incidence of sleep disorder and effect of oral almond on sleep quality in medical science students in tehran university of medical sciences
Public title
Investigating the impact of sweet almond on sleep quality.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: students of Tehran University of Medical Science and written consent.
Exclusion criteria: medical interns , residents and students with a history of physiological disorder.
Age
From 18 years old to 30 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of the Iran University of Medical Sciences
Street address
School of Traditional Medicine,Hafez Street,Tehran,Iran.1143995711
City
Tehan
Postal code
11439957181
Approval date
2016-12-13, 1395/09/23
Ethics committee reference number
ir.iums.rec.1395.9321309005
2
Ethics committee
Name of ethics committee
Ethical Committee of the Iran University of Medical Sciences, School of Traditional Medicine
Street address
Hafez Street , Behesht avenue's corner
City
Tehran
Postal code
1439957181
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ir.iums.rec.1395.9321309005
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
-G47.0
ICD-10 code description
-Disorders of initiating and maintaining sleep
Primary outcomes
1
Description
Insomnia
Timepoint
Onset of study, 2 weeks later
Method of measurement
ISI questionnaire score
Secondary outcomes
1
Description
Improvement of sleep quality
Timepoint
Two weeks after the intervention
Method of measurement
Questionnaire score
Intervention groups
1
Description
Initially the quality of sleep will be assessed; then by using a before-after design, the cases will serve as their own controls.Each sample member will take 10
sweet almonds for two weeks; then the quality of sleep will be assessed again by a standard questionnaire.This is a before-after study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Dr Ghafarzadeh Jafar. Head of dormitory Affairs
Street address
No 1472, Karegar Shomali Street,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research, Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Hemat High way Iran University of Medical Siences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Traditional Medicine , Iran University of Medical Sciences
Full name of responsible person
Ghafarzadeh Jafar
Position
Resident
Other areas of specialty/work
Street address
Hafez Street, Behesht Street
City
Tehran
Postal code
1439957181
Phone
+98 21 8800 5291
Fax
+98 21 8800 2651
Email
ghafarzadeh.j@tak.iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine , Iran University of Medical Sciencs
Full name of responsible person
Dr Amini Behbehani Farshad
Position
Asistant professor
Other areas of specialty/work
Street address
Hafez Street, Behesht Street
City
Tehran
Postal code
1439957181
Phone
+98 21 5558 0388
Fax
+98 21 8800 2651
Email
aminibehbehani.f@iums.ac.ir
Web page address
www.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine , Iran University of Medical Sciences